Social Cognition Individualized Activities Lab for Social Cognition Training and Narrative Enhancement in Patients With Schizophrenia: A Randomized Controlled Study to Assess Efficacy and Generalization to Real-Life Functioning (Prot. n°: NCT05130853)

Abstract

Subjects affected by schizophrenia present significant deficits in various aspects of social cognition, such as emotion processing, social perception and theory of mind (ToM). These deficits have a greater impact than symptoms on occupational and social functioning. Therefore, social cognition represents an important therapeutic target in people with schizophrenia. Recent meta-analyses showed that social cognition training (SCT) is effective in improving social cognition in subjects with schizophrenia; however, real-life functioning is not always ameliorated. Integration of SCT with an intervention targeting metacognitive abilities might improve the integration of social cognitive skills to daily life functioning. Our research group has implemented a new individualized rehabilitation program: the Social Cognition Individualized Activities Lab, SoCIAL, which integrates SCT with a module for narrative enhancement, an intervention targeting metacognitive abilities. The present multi-center randomized controlled study will compare the efficacy of SoCIAL and treatment as usual (TAU) in subjects diagnosed with a schizophrenia-spectrum disorder. The primary outcome will be the improvement of social cognition and real-life functioning; while the secondary outcome will be the improvement of symptoms, functional capacity and neurocognition. The results of this study will add empirical evidence to the benefits and feasibility of SCT and narrative enhancement in people with schizophrenia-spectrum disorders.

Second-Generation Antipsychotics’ Effectiveness and Tolerability: A Review of Real-World Studies in Patients with Schizophrenia and Related Disorders

“…Only a few studies directly evaluated the therapeutic effects of SGAs on positive, negative, and affective symptoms [ 41 , 42 , 46 , 55 , 56 ], and none reported antipsychotic effectiveness in disabling cognitive symptoms.…”

“…In addition, all LAI APs appeared to be associated with a lower risk of rehospitalization also when compared with the equivalent oral formulations (i.e., oral olanzapine) [ 44 ]. Switching from oral SGAs or FGAs to LAIs or APs polytherapy in early non-responders appeared beneficial for preventing treatment failure in hospitalized patients with acute schizophrenia [ 46 , 65 ]. Better relapse prevention and clinical stability were achieved by switching from one LAI to another when deemed necessary [ 65 ].…”

“…One of the most considerable challenges in treating patients with schizophrenia and related disorders is the life-long functional disability associated with negative symptoms, cognitive impairment, and increased treatment resistance after each acute episode. Consequently, the primary goal of antipsychotic treatment should be not only to achieve a partial (or optimal) remission of symptoms in the acute phase but also to improve long-term outcomes and reduce the risk of secondary negative symptoms and worsening of cognitive impairment [ 45 , 46 ].…”

Combining transcranial magnetic stimulation with training to improve social cognition impairment in schizophrenia: a pilot randomized controlled trial

“…by using the software COGPACK (version 9.3, Marker Software, Ladenburg, Germany), described in detail in another work (Vergallito et al, 2023a). Materials from the Social Cognition Individualized Activities Lab (SoCIAL) (Palumbo et al, 2017(Palumbo et al, , 2022 were used to train social cognition abilities. The Emotion recognition module was administered in the first seven sessions.…”

“…For the cognitive training, which is described in detail elsewhere(Vergallito et al, 2023a), we used individually targeted exercises from the Cogpack software. For the social cognitive training, we used materials from the SoCIAL in an individual setting(Palumbo et al, 2017(Palumbo et al, , 2022. The social cognition training included a first module, in which we trained participants to recognize emotions from static facial pictures and short video clips.…”